Merck...announced the European Commission (EC) has approved two new indications for KEYTRUDA, Merck’s anti-PD-1 therapy, in gastrointestinal cancers...KEYTRUDA in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1.

Pts with previously untreated HER2-negative locally advanced or metastatic G/GEJ adenocarcinoma with known PD-L1 CPS were randomized 1:1 to pembro 200 mg (pembro arm) or pbo...Median OS was 17.3 mo (95% CI, 14.8-19.5) for the pembro arm vs 13.0 mo (11.8-14.4) for the pbo arm (HR, 0.71; 95% CI, 0.58-0.87); median PFS was 8.4 mo (95% CI, 7.2-9.6) for the pembro arm vs 6.7 mo (5.7-6.9) for the pbo arm (HR, 0.69; 0.57-0.85). ORR was 61.2% in the pembro arm and 48.9% in the pbo arm...Consistent with the global KEYNOTE-859 results, the addition of pembro to FP or CAPOX provided improvement in OS, PFS, and ORR numerically, with no new safety signals for pts enrolled in Asia. Results continue to support pembro + chemo as a 1L treatment option for pts with locally advanced or metastatic HER2-negative G/GEJ adenocarcinoma.